Senior Clinical Data Manager — Trials & Data Quality

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Kaztronix is seeking a Clinical Data Manager to oversee data management for Phase I-III trials in line with ICH/GCP guidelines. The role focuses on delivering high-quality data on time and within budget, coordinating with multidisciplinary teams and ensuring regulatory compliance.

Responsibilities include creating and reviewing CDM documents, performing UAT/QC, coordinating with programmers on data flow specs, training sites, resolving data issues, and archiving study data after trial completion.

Qualifications

• Minimum 5 years of data management experience.
• Experience with Electronic Data Capture (EDC) systems is required.
• Experience with Oracle InformTM EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience within Data Management is preferred.

Responsibilities

• Serve as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
• Communicate key clinical data management metrics and determine actions with the study team.
• Review, develop and/or write CDM documents and manuals (CRFs, edit checks, DMPs, eCRF guidelines).
• Participate in UAT and QC as needed.
• Work with the Clinical Database Programmer to develop Data Flow Charts and Import Guidelines.
• Assist with site and third-party vendor training on CDM topics.
• Provide data review training and guidance to Senior Clinical Data Coordinators.
• Perform data review and discrepancy resolution.
• Archive trial documentation upon completion.
• Ensure adherence to GCP and applicable regulations.

Skills

EDC systems experience

Data management

Project management in DM

Regulatory compliance (ICH/GCP)

Education

Bachelor's degree or allied health certification

Tools

Oracle InformTM EDC

Job description

Kaztronix is seeking a Clinical Data Manager to oversee data management for Phase I-III trials in line with ICH/GCP guidelines. The role focuses on delivering high-quality data on time and within budget, coordinating with multidisciplinary teams and ensuring regulatory compliance.

Responsibilities include creating and reviewing CDM documents, performing UAT/QC, coordinating with programmers on data flow specs, training sites, resolving data issues, and archiving study data after trial completion.